Hi,
Role:- Verification & Validation Engineer Location:-Milwaukee WI Duration:-12+ Months *Need:- USC Only* Role Verification & Validation Engineer Mandatory Technical Skills • BSEE/BSCS or equivalent Technical Degree • Experience as a Verification and Validation Engineer for 5+ years • Strong knowledge of Microsoft Windows technologies • Excellent communication skills, written and verbal • Detail oriented and meticulous worker • Good organizational skills in recording test results • Strong belief in quality compliance and following rules • Strong working experience on setting up lab test equipment and setting up PC and Servers and deploying software onto target systems • Knowledge of testing medical products • Knowledge of FDA regulations required to test medical products Desirable Technical Skills • • Experienced in Software Development Life Cycle (SDLC) Waterfall and Agile methodologies, Manual Testing, White Box and Black Box Testing, Validation and Verification testing. • Experienced in testing Software, Web Applications, IVR, System Components, and Database • Experienced in System Performance, Unit, Functional, Regression, Integration and User Acceptance Testing. • Participated in writing and implementing Test Plans, Test Cases and Test Scripts/Protocols and Traceability Matrix. Executed Test Scripts/Protocols and documented Test Results. Edited and re-tested Test Scripts/ Protocols and signed off (Pass/Fail) • Participated in Requirements gathering, Code Reviews/ Walk Trough. • Hands-on experienced in Automated Test Tool –Mercury Win Runner, Load Runner and Test Director. • Created defect tracking (manual repository), maintained and updated defect statuses and timelines. • Exposure in Risk Assessment and Testing Methodologies. • Exposure to Protocol Creation, Execution –IQ, PQ • Complaints Investigation for Medical Device (CAPA) • Exposure in FDA Regulations – GMP, CGMP, GAMP, GXP, QSI, 21 CFR Part 11 and CFR Part 820, ISO 14971, Risk Assessment for Medical Device, ISO 1345, IEC 62304 – International Standards (Europe and US) • and IEEE, SEI, Six Sigma and other ISO standards and regulations. • Hands on use of ETQ, Documentum, Trackwise ,LIMS ePAS, DMS (Data Management System), EDMS, Citrix, AMM (AS/400), Citrix and Cognos, HL7 – Logix OE, Logix OE, Documentum. Mandatory Functional Skills 1. Create and revise Design Verification and Validation (V&V) Procedures 2. Participate in Design Verification and Validation Procedure Reviews 3. Setup and configure Test Equipment 4. Perform dry runs and formal Verification and Validation (V&V) activities as required 5. Perform dry runs for formal Usability test activities as required 6. Perform remediations of V&V results as required 7. Record and close defects found during V&V activities 8.Computer Software Validation (CSV) Test/ Protocol execution for the implementation of EtQ Symphony Reliance Quality Management System –Process Validation (PQ) 9. Performed Dry run –Data Set Up (Role based), test script/ protocol execution for CAPA and Investigations, per Business, Functional Requirements and User Requirements and identify deviations (TDRs) – system, design, logic/ workflow and documentations that complies with cGMP,GxP-FDA compliance regulated computerized system that supports the Johnson & Johnson Group of Consumer Companies (JJGCC), providing CD (Consent Decree) computer validation technical consulting services for the implementation of EtQ Symphony Reliance Quality Management System –Process Validation 10. Performed execution of approved test scripts to validate Test Results conforms with Design, FRS, URS, SOPs,Traceability Matrix in compliance with cGMP and GDP requirements. *Saurabh Sharma* *Sr. Recruiter – IT Services* [image: cid:image003.jpg@01D08EFC.585A4C80] *SAP AND IT CONSULTING SERVICES * 9622 Blackberry Terrace Dr, Spring, TX 77379 T: 281 954 5503 | 281 954 5922 Email: saur...@e-infionics.com <raj...@e-infionics.com> | saurabhsysmind...@gmail.com Web: www.e-infionics.com *[image: Description: linkedin_logo]www.linkedin.com/hp/?dnr=MmIAbTl2WozUrjowMgyhfSxwWozVPjlMNWqz <http://www.linkedin.com/hp/?dnr=MmIAbTl2WozUrjowMgyhfSxwWozVPjlMNWqz>* -- You received this message because you are subscribed to the Google Groups "International SAP Projects" group. To unsubscribe from this group and stop receiving emails from it, send an email to international-sap-projects+unsubscr...@googlegroups.com. To post to this group, send email to international-sap-projects@googlegroups.com. Visit this group at http://groups.google.com/group/international-sap-projects. For more options, visit https://groups.google.com/d/optout.
